BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE

    K Number: K082092 · Decision Oct 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
    K Number
    K082092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Galemed Corp.
    Date Received
    July 24, 2008
    Decision Date
    October 15, 2008
    Product Code
    BTM
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTM Ventilator, Emergency, Manual (Resuscitator)

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    Other Clearances by Galemed Corp.

    K Number Device Name
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    K133957 DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE
    K122627 GIO DIGITAL PRESSURE GUAGES
    K072755 GALEMED CPAP MASK
    K022124 GALEMED PEAK FLOW METER, MODELS 3751/3752
    K021742 GALEMED NEB-EASY NEBULIZER